New Techniques for Diagnosis and Treatment of Cognitive Impairment in Affective Disorder

Research on New Techniques for Diagnosis and Treatment of Neuropsychiatric Diseases - Research on New Techniques for Diagnosis and Treatment of Affective Disorders and Cognitive Impairment

The purpose of this study is to explore the pathological mechanism of cognitive impairment in patients with affective disorder based on brain gut axis research, preliminarily verify the clinical efficacy of new neural regulation technology on cognitive impairment, and establish an evaluation model to predict the efficacy of physical therapy for affective disorder.

Study Overview

• Status: Recruiting
• Conditions: Affective Disorder
• Intervention / Treatment: Device: Transcranial magnetic stimulation; Device: Transcranial direct current stimulation

• Study Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hu ShaoHua, M.D; Phone Number: +86 13357169115; Email: dorhushaohua@zju.deu.cn
• Study Contact Backup: Name: Wang DanDan; Phone Number: +86 18867132330; Email: 851176155@qq.com

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Recruiting
      • The First Affiliated Hospital of Zhejiang University
      • Contact: Hu ShaoHua; Phone Number: 13957162903; Email: dorhushaohua@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age 16-65 years old, regardless of gender;
2. Meet DSM-V diagnostic criteria for depression or bipolar disorder;
3. Duration of stable period ≥ 3 months;
4. Young Mania Rating Scale (YMRS) ≤ 6 points;
5. Hamilton Depression Rating Scale 17 - item (HDRS-17) score ≤ 7;
6. The score of cognitive defects questionnaire (PDQ) ≥ 17;
7. Han nationality, right-handed;
8. More than 9 years of education.

Exclusion Criteria:

1. History of severe somatic or brain organic diseases and craniocerebral trauma;
2. Abnormal brain structure or any MRI contraindications were found by magnetic resonance examination;
3. Those who do not cooperate or cannot effectively complete the experiment;
4. Drug, alcohol or other psychoactive substance abusers;
5. Pregnant, lactating or planned pregnancy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Transcranial magnetic stimulation	Device: Transcranial magnetic stimulation; Setting up a new target for rTMS. In the past research, the common target of rTMS in the treatment of cognitive impairment of affective disorder was left Dorsolateral prefrontal CORTEX (DLPFC) . The left lateral DLPFC and the primary visual Cortex (V1) both play important roles in cognitive process. The regions with the strongest functional connection between V1 and DLPFC were selected as the stimulation targets.
Experimental: Transcranial direct-current stimulation	Device: Transcranial direct current stimulation; Targeted multi-channel tDCS based on individualized simulation scale can be combined with individualized simulation modeling optimization, and based on individual MRI information, through quantitative evaluation and intelligent algorithms to achieve stimulation parameter optimization, reduce the stimulation dose to non-target target areas, and improve target brain stimulation The treatment targeting and aggregation of the area can realize personalized and precise treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wechsler Memory Scale	The Wechsler Memory Scale score was used to evaluate the degree of cognitive function, and the lower the score, the more severe the cognitive function impairment. The scoring threshold is 70 points. A lower score means more severe cognitive impairment.	0-8 weeks

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): October 1, 2024

Study Registration Dates

• First Submitted: May 26, 2022
• First Submitted That Met QC Criteria: October 26, 2022
• First Posted (Actual): October 27, 2022

Study Record Updates

• Last Update Posted (Estimate): March 10, 2023
• Last Update Submitted That Met QC Criteria: March 9, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction; Mood Disorders
• Other Study ID Numbers: IIT20210036C-R1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No